Alzheimer DiseaseNCT04439097
Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease
A study testing Multicomponent physical exercise program associated with a Mediterranean diet in people with Alzheimer Disease and Physical Exercise, run by University of Salamanca at 1 site in Spain.
Trial summary
This study is a randomized, parallel-group, single blinded controlled clinical trial. The general objective of this multicomponent physical exercise program (MPEP) associated with a Mediterranean Diet (MeDi) is to decrease the risk of falls and fractures through the improvement of the bone health and physical… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Physical Exercise, Bone Density
- What is being tested?
- Multicomponent physical exercise program associated with a Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes older than 50 years
- Have a diagnosis of AD
- Present mild or moderate cognitive impairment (Mini-mental State Examination (MMSE) score between 11 and 23 points included)
- Acceptance to participate in the study (enrollment in the study and signing of informed consent)
Who cannot join
- Other associated pathologies that do not allow physical exercise due to having severe functional disability or being insecure (neurological diseases, severe cardio-respiratory pathology, etc.).
- Impossibility to carry out the evaluation tests.
- Falls and other incidents with severe consequences that cause disability and/or that do not allow the intervention to continue.
- Attendance at the MPEP is less than 75% in the total of the sessions between assessments. (Criterion applied to each period between assessments).
- Not performing the MPEP sessions for 2 or more consecutive weeks.
- Participate in another intervention program outside of this study, especially an exercise program (important intervention bias for the control group).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short and Medium-term Effects of a Multicomponent Physical Exercise Program With a Mediterranean Diet on Bone Mineral Density, Gait, Balance, and Fall Risk for Patients With Alzheimer's Disease: Randomized Controlled Clinical Trial Study Protocol
This study is a randomized, parallel-group, single blinded controlled clinical trial. The general objective of this multicomponent physical exercise program (MPEP) associated with a Mediterranean Diet (MeDi) is to decrease the risk of falls and fractures through the improvement of the bone health and physical functions of people with Alzheimer Disease.
Patients allocated to the intervention group will perform a MPEP with a MeDi during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session.
During the study, 4 evaluations will be carried out to assess the effects of the interventions on bone mineral density, gait, balance, and fall risk: ((1) Baseline (pre-intervention); 2) 1st post-intervention after 1 month; 3) 2nd post-intervention after 3 months; 4) Final, 3rd post-intervention after 6 months
- Conditions
- Alzheimer Disease, Physical Exercise, Bone Density, Fall
- Being tested
- Multicomponent physical exercise program associated with a Mediterranean diet, Usual care
- Medical subject headings
- Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent physical exercise program associated with a Mediterranean dietOther
In this basic structure of each sessions, traditional exercises of mobility, strength, balance and coordination are included with the main objective of improving functional capacities. But, besides, games and some activities are also included with the aim, not only of improving the functional capacity, but also working the cognitive functions to reinforce the global effects.
The Mediterranean diet will based in these main foods: 1) vegetables; 2) fruits; 3) fish or seafood; 4) legumes; 5) nuts; 6) bread or cereals; 7) white meat; 8) eggs; and 9)olive oil.
Usual careOther
Usual care and participants continue with their life normally, without participating in a standardized exercise program, and they will be instructed to maintain their current physical activity level.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients allocated to the intervention group will perform a MPEP during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session. In addition, they will have a Mediterranean Diet.
The patients in the MPEP will be carried out in small groups of 5-8 people. Structure of sessions: 3 different parts: an initial warm-up, a main part and a final cool-down and relaxation. Receives: Other: Multicomponent physical exercise program associated with a Mediterranean diet |
| Control Group | Active comparator | Participants allocated to the control group will receive usual care and continue with their life normally, without participating in a standardized exercise program. They will be instructed to maintain their current physical activity level. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait and balance 1
Tinetti's Performance Oriented Mobility Assessment (POMA-T) will be used (points). the original POMA-T 28-point version. It consists of a balance scale (Balance performance oriented mobility assessment (POMA-B) can score 16 points) and a gait scale (Gait performance oriented mobility assessment (POMA-G) can score 12 points )
Measured: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in gait and balance 2
Timed up and go test (TUG) will be used (s). IT measures the time in seconds for the subjects to get up from a standard armchair, walk 3 metres, turn, walk back to the chair and sit down. The cut-off point for normal mobility is 12 seconds and values > 30 s indicate a high level of dependence. (a time <10s it is considered normal; <20s mobility difficulties and low or moderate risk of falls; > 20 mobility problems with need of help and high risk of falls)
Measured: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in Bone Mineral Density (BMD)
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As primary outcome we will assess the estimated BMD (g/cm2).
Measured: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in T-Score as primary parameter of bone health
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As primary outcome we will assess the T-Score. A T-score shows how much the BMD is higher or lower than the BMD of a healthy 30-year old adult. (-1.0 or above normal BMD; From -1.0 to -2.5 low BMD or osteopenia; -2.5 or below very low BMD and diagnosis of osteoporosis.
Measured: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Secondary outcomes (7)
Change in static balance
one-leg balance test (OLB) will be used (s). This test assess the ability of the patients to remain upright on one leg without support for at least 5 seconds, and each leg was tested.
Measured: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in proactive balance
Functional reach test (FR) will be used (cm). Is a measure of the distance in centimeters that the standing participant is able to reach forward from an initial upright posture to the maximal anterior leaning posture without moving or lifting the feet.
Measured: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Falls during the study
The number of falls of each subject during the study will be counted
Measured: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the Broadband ultrasound attenuation (BUA) as secondary parameter of bone health
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcome we will assess the Broadband ultrasound attenuation (BUA) (dB/MHz). It is a measurement of the differential attenuation of sound waves transmitted through the calcaneus.
Measured: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the Speed of sound (SOS) as secondary parameter of bone health
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcomes we will assess the SOS through the calcaneus bone (m/s). It is calculated as the ratio of the distance traveled by the impulse and the time taken by the signal to travel that distance
Measured: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the Quantitative ultrasound index (QUI) as secondary parameter of bone health
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcomes we will assess the Quantitative ultrasound index. To improve precision we will calculate de QUI, a variable derived from the mathematical combination of both SoS and BUA [0.41 × (BUA + SoS) - 571] (19), expressed as percent.
Measured: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the nutritional status
Nutritional status will be assessed by the Mini Nutritional Assessment (MNA) (points). Total score ranging from 0 to 30. Well nourished (MNA score >23.5), at risk of malnutrition (MNA score=17.0-23.5), or malnourished (MNA score <17).
Measured: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start15 Sep 2021 (estimated)
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized parallel-group, single blinded controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Méndez Sánchez, University of Salamanca
- Investigators
- Roberto Méndez-Sánchez, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439097
- Sponsor's protocol ID
- 02102009-USalamanca
- Status last verified
- Mar 2021
- First submitted
- 15 Jun 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puente-Gonzalez AS, Sanchez-Gonzalez F, Hernandez-Xumet JE, Sanchez-Sanchez MC, Barbero-Iglesias FJ, Mendez-Sanchez R. Short and medium-term effects of a multicomponent physical exercise program with a Mediterranean diet on bone mineral density, gait, balance, and fall risk for patients with Alzheimer disease: Randomized controlled clinical trial study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22385. doi: 10.1097/MD.0000000000022385.
PubMed 32957420
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Medium-term Effects of a Multicomponent Physical Exercise Program With a Mediterranean Diet on Bone Mineral Density, Gait, Balance, and Fall Risk for Patients With Alzheimer's Disease: Randomized Controlled Clinical Trial Study Protocol
- ClinicalTrials.gov ID
- NCT04439097
- Acronym / sponsor ID
- 02102009-USalamanca
- Conditions
- Alzheimer Disease, Physical Exercise, Bone Density, Fall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, parallel-group, single blinded controlled clinical trial. The general objective of this multicomponent physical exercise program (MPEP) associated with a Mediterranean Diet (MeDi) is to decrease the risk of falls and fractures through the improvement of the bone health and physical functions of people with Alzheimer Disease.
Patients allocated to the intervention group will perform a MPEP with a MeDi during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session.
During the study, 4 evaluations will be carried out to assess the effects of the interventions on bone mineral density, gait, balance, and fall risk: ((1) Baseline (pre-intervention); 2) 1st post-intervention after 1 month; 3) 2nd post-intervention after 3 months; 4) Final, 3rd post-intervention after 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized parallel-group, single blinded controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Multicomponent physical exercise program associated with a Mediterranean dietPatients allocated to the intervention group will perform a MPEP during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session. In addition, they will have a Mediterranean Diet. The patients in the MPEP will be carried out in small groups of 5-8 people. Structure of sessions: 3 different parts: an initial warm-up, a main part and a final cool-down and relaxation. |
| Control Group | Active comparator | Other: Usual careParticipants allocated to the control group will receive usual care and continue with their life normally, without participating in a standardized exercise program. They will be instructed to maintain their current physical activity level. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes older than 50 years
- Have a diagnosis of AD
- Present mild or moderate cognitive impairment (Mini-mental State Examination (MMSE) score between 11 and 23 points included)
- Acceptance to participate in the study (enrollment in the study and signing of informed consent)
Key exclusion criteria (6 listed)
- Other associated pathologies that do not allow physical exercise due to having severe functional disability or being insecure (neurological diseases, severe cardio-respiratory pathology, etc.).
- Impossibility to carry out the evaluation tests.
- Falls and other incidents with severe consequences that cause disability and/or that do not allow the intervention to continue.
- Attendance at the MPEP is less than 75% in the total of the sessions between assessments. (Criterion applied to each period between assessments).
- Not performing the MPEP sessions for 2 or more consecutive weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent physical exercise program associated with a Mediterranean dietIn this basic structure of each sessions, traditional exercises of mobility, strength, balance and coordination are included with the main objective of improving functional capacities. But, besides, games and some activities are also included with the aim, not only of improving the functional capacity, but also working the cognitive functions to reinforce the global effects. The Mediterranean diet will based in these main foods: 1) vegetables; 2) fruits; 3) fish or seafood; 4) legumes; 5) nuts; 6) bread or cereals; 7) white meat; 8) eggs; and 9)olive oil. | Other | Experimental Group |
| Usual careUsual care and participants continue with their life normally, without participating in a standardized exercise program, and they will be instructed to maintain their current physical activity level. | Other | Control Group |
Primary outcome
Change in gait and balance 1
Time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Tinetti's Performance Oriented Mobility Assessment (POMA-T) will be used (points). the original POMA-T 28-point version. It consists of a balance scale (Balance performance oriented mobility assessment (POMA-B) can score 16 points) and a gait scale (Gait performance oriented mobility assessment (POMA-G) can score 12 points )
Change in gait and balance 2
Time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Timed up and go test (TUG) will be used (s). IT measures the time in seconds for the subjects to get up from a standard armchair, walk 3 metres, turn, walk back to the chair and sit down. The cut-off point for normal mobility is 12 seconds and values > 30 s indicate a high level of dependence. (a time <10s it is considered normal; <20s mobility difficulties and low or moderate risk of falls; > 20 mobility problems with need of help and high risk of falls)
Change in Bone Mineral Density (BMD)
Time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As primary outcome we will assess the estimated BMD (g/cm2).
Change in T-Score as primary parameter of bone health
Time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As primary outcome we will assess the T-Score. A T-score shows how much the BMD is higher or lower than the BMD of a healthy 30-year old adult. (-1.0 or above normal BMD; From -1.0 to -2.5 low BMD or osteopenia; -2.5 or below very low BMD and diagnosis of osteoporosis.
7 secondary outcomes
Change in static balance
Time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in proactive balance
Time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Falls during the study
Time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the Broadband ultrasound attenuation (BUA) as secondary parameter of bone health
Time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the Speed of sound (SOS) as secondary parameter of bone health
Time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the Quantitative ultrasound index (QUI) as secondary parameter of bone health
Time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the nutritional status
Time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Derived from this study: PubMed 32957420Puente-Gonzalez AS, Sanchez-Gonzalez F, Hernandez-Xumet JE, Sanchez-Sanchez MC, Barbero-Iglesias FJ, Mendez-Sanchez R. Short and medium-term effects of a multicomponent physical exercise program with a Mediterranean diet on bone mineral density, gait, balance, and fall risk for patients with Alzheimer disease: Randomized controlled clinical trial study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22385. doi: 10.1097/MD.0000000000022385.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Méndez-Sánchez, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent physical exercise program associated with a Mediterranean diet in people with Alzheimer Disease and Physical Exercise, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Méndez-Sánchez, PhD ((34)923294400 ext. 3201, ro_mendez@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait and balance 1 (time frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04439097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.